BMC surgery · 2026
Robotic right hemicolectomy with intracorporeal anastomosis versus laparoscopic right hemicolectomy with extracorporeal anastomosis (PRORHEM): protocol for a randomized controlled trial.
Протокол клинического исследованияСравнительное исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Meyer Jeremy, Liot Emilie, Meurette Guillaume, Toso Christian, Ris Frédéric
Аннотация
BACKGROUND: In laparoscopic right hemicolectomy (lapRHC) for colorectal cancer, intra-corporeal anastomosis (ICA) has been associated with faster recovery and lower incidence of incisional hernia (IH) compared with extra-corporeal anastomosis (ECA). However, due to technical constraints, ICA is not widely adopted, and ECA remains the standard approach. Robotic surgery, with enhanced dexterity and suturing capability, facilitates ICA and may therefore improve short-term outcomes and reduce IH incidence.
METHODS: We designed a monocentric, double-blind randomized controlled trial to compare robotic right hemicolectomy (robRHC) with D2 lymphadenectomy, ICA, and off-midline extraction (fully minimally invasive) versus lapRHC with D2 lymphadenectomy, ECA, and midline extraction (standard of care). The primary endpoint is bowel recovery, assessed by time to first passage of stool. Secondary endpoints include perioperative safety (morbidity, mortality, resection margins, lymph node yield), length of stay, IH incidence, and patient-reported esthetic and quality-of-life outcomes. Based on a hypothesized 1-day reduction in bowel recovery, a total of 70 patients will be randomized.
ETHICS AND DISSEMINATION: The trial complies with the Declaration of Helsinki, ICH-GCP, and Swiss regulatory standards. It has been approved by the local ethics committee (CCER 2024 - 00975) and registered in ClinicalTrials.gov (NCT06067620, 09.05.2024).
METHODS: We designed a monocentric, double-blind randomized controlled trial to compare robotic right hemicolectomy (robRHC) with D2 lymphadenectomy, ICA, and off-midline extraction (fully minimally invasive) versus lapRHC with D2 lymphadenectomy, ECA, and midline extraction (standard of care). The primary endpoint is bowel recovery, assessed by time to first passage of stool. Secondary endpoints include perioperative safety (morbidity, mortality, resection margins, lymph node yield), length of stay, IH incidence, and patient-reported esthetic and quality-of-life outcomes. Based on a hypothesized 1-day reduction in bowel recovery, a total of 70 patients will be randomized.
ETHICS AND DISSEMINATION: The trial complies with the Declaration of Helsinki, ICH-GCP, and Swiss regulatory standards. It has been approved by the local ethics committee (CCER 2024 - 00975) and registered in ClinicalTrials.gov (NCT06067620, 09.05.2024).